NDC 68084-446-11 - Nitrofurantoin (monohydrate/macrocrystals)

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 68084-446
Requested NDC: 68084-446-11
Package NDCs from labels: 68084-446-11, 68084-446-01
Manufacturer: American Health Packaging
Effective date: 2022-10-19
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Nitrofurantoin (monohydrate/macrocrystals) - American Health Packaging	American Health Packaging	2022-10-19	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-446-01	EA - Each	68084-446	3531bb3c-0cf0-4c41-ac4f-07e04cce7341	1	2012-07-24
68084-446-11	EA - Each	68084-446	c2e616ac-22cd-4470-8909-ecaf9f724e9b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NITROFURANTOIN	ACTIVE INGREDIENT	927AH8112L	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
NITROFURANTOIN MONOHYDRATE	ACTIVE INGREDIENT	E1QI2CQQ1I	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
NITROFURANTOIN	ACTIVE MOIETY	927AH8112L	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	Z135WT9208	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 74 of 140 · 2,782 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sun Bum 50 Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Sun Bum, LLC	3a263b85-e7a0-c068-e063-6294a90a49f2	2025-08-14	Warnings	Exact identifier unii: 15FIX9V2JP
Sun Bum 50 Mineral Sunscreen Roll-On	TITANIUM DIOXIDE, ZINC OXIDE	Sun Bum, LLC	3a392237-019d-2384-e063-6394a90a5b24	2025-08-14	Warnings	Exact identifier unii: 15FIX9V2JP
NITROFURANTOIN	NITROFURANTOIN	Camber Pharmaceuticals, Inc.	4e06b31e-cc49-4526-beb6-e77021823aa9	2025-08-13	Warnings, Adverse reactions	Exact identifier unii: 927AH8112L
Schuessler Tissue Salts Comb D Skin Disorders	KALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEA	Martin & Pleasance Pty Ltd	617303f8-4463-4a1e-a502-44abc181d91f	2025-08-13	Warnings	Exact identifier unii: ETJ7Z6XBU4
Schuessler Tissue Salts Comb D Skin Disorders	KALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEA	Martin & Pleasance Pty Ltd	03153d92-dc68-4b84-a8c9-634b1ffd7da1	2025-08-13	Warnings	Exact identifier unii: ETJ7Z6XBU4
Silk Screen	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c457455-b9b1-546b-e063-6294a90a41f6	2025-08-13	Warnings	Exact identifier unii: 15FIX9V2JP
Baby Bum Mineral 50 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Sun Bum, LLC	3c470ff8-37d6-a729-e063-6294a90aa525	2025-08-13	Warnings	Exact identifier unii: 15FIX9V2JP
100% MINERAL SUNSCREEN	100% MINERAL SUNSCREEN	Guangzhou Pallas Cosmetics Co.,Ltd.	3c4a3b41-9183-3835-e063-6394a90aea61	2025-08-13	Warnings	Exact identifier unii: 15FIX9V2JP
Nitrofurantoin	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	A-S Medication Solutions	b644426c-c8ba-4fe0-80c7-d9b2dde37395	2025-08-13	Warnings, Adverse reactions	Exact identifier application number: ANDA077066 rxcui: 1648755 unii: E1QI2CQQ1I unii: 927AH8112L
ERBORIAN CC CREME Color Correcting SPF 25 FAIR	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	4443d4e6-bdc9-4547-9189-e94e9e0bdd2d	2025-08-12	Warnings	Exact identifier unii: 15FIX9V2JP
ERBORIAN CC Red Correct Color Correcting SPF 25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	a6cd16cc-5fe3-41b5-b724-83e469cd4d5e	2025-08-12	Warnings	Exact identifier unii: 15FIX9V2JP
ERBORIAN CC CREME Color Correcting SPF 25 BRONZE	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	4aa12cf0-0c48-4b40-9c9a-bd50523cce8a	2025-08-12	Warnings	Exact identifier unii: 15FIX9V2JP
ERBORIAN CC CREME Color Correcting SPF 25 MEDIUM	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	5bdaa149-47aa-40ac-b17a-ea6d29099862	2025-08-12	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	15536331-fec5-4daa-824d-2e32d63e6452	2025-08-12	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 22N Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	ad8afa83-2844-422c-b2bf-b5a61be368b1	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 23W Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	96973dee-681b-4c5d-b31f-de05cd79fa18	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 24N Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	ecda3658-eca1-48c2-9eff-e22fd1ff70df	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 25W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	c6f27df4-6de4-45e4-90cb-ea8b0d29dbd3	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 26W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	968abacd-8b99-4529-a627-2b56cdf99e1b	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 27N Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	a9068dc0-bc48-498b-adc9-57ff810384af	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.